Healthcare professionals in General Anesthesia, Intensive Care and Emergency Medicine use over 60 million ETTs a year to manage patient airways. The vast majority of ETTs utilize an inflatable cuff that forms a pneumatic seal with the patient's trachea to prevent air leakage and aspiration during patient ventilation after the ETT has been placed in the patient's trachea through intubation. Multiple studies suggest that maintaining cuff pressure at 20-30 cm H2O is critical for patient safety; pressures below 20 cm H2O have been shown to increase the risk of Ventilator Associated Pneumonia (VAP) and pressures above 30 cm H2O are associated with a higher risk of stenosis, ischemia and rupture of the trachea. Despite the severity and high costs of these complications, unsafe cuff pressures have been observed in over half of intubated patients at numerous hospitals and EMT units.
There are two conventional techniques to inflate an ETT cuff: (1) subjective feedback based on the pressure of the external palpation balloon and (2) inflating a set volume of air based on the selected cuff size. These methods have been shown to be inaccurate even in the hands of experienced professionals. Studies comparing hospitals with high and low rates of unsafe cuff pressures have found that hospitals using pressure meters to check cuff pressure upon inflation outperformed hospitals relying on conventional techniques utilizing no peripheral instrumentation.
Some hospitals use a Cufflator or similar blood pressure meter to measure and monitor cuff pressure. The Cufflator is an analog pressure gauge attached to a compressible rubber handle that, when squeezed, acts as a bellow and inflates the cuff. The Cufflator is bulky, expensive, and has been shown to be inaccurate by as much as 4 cm H2O. Consequently, many hospitals prefer to use blood pressure meters in conjunction with a T-valve and a syringe. Although less expensive and more accurate than the Cufflator, connecting these three devices together to inflate the cuff introduces more procedural time. Set-up time aside, both the Cufflator and blood pressure meter require training; (1) users must know the proper pressure to leave the cuff and (2) users must know to inflate the cuff to an excessively high pressure before lowering it to the final pressure. The latter requirement is an accepted practice of experienced Respiratory Therapists to establish a creaseless seal between the cuff and the trachea.
U.S. Pat. Nos. 4,367,739, 4,370,982, 5,074,443, 5,270,685, 5,163,904, 4,064,879, 4,624,659, 4,475,906, 6,605,064, 4,178,938 4,178,940, and 5,015,233, the entire disclosures of which are incorporated herein by reference, illustrate several prior art syringes and other apparatuses that have been used for inflating ETT cuffs and which suffer from the disadvantages discussed above. Therefore, it would be beneficial to provide an accurate, reliable, and/or cost efficient means to automatically establish a safe ETT cuff pressure.
There is a long-felt, unmet need for an improved apparatus and related methods for inflating an ETT cuff to a safe pressure. The present general inventive concept provides an accurate, reliable, and/or cost efficient means to automatically establish a safe ETT cuff pressure with a single full stroke of the syringe.